Cinch device and method for deployment of a side-delivered prosthetic heart valve in a native annulus

ABSTRACT

The invention relates to anchor channels and subannular anchors for a transcatheter heart valve replacement (A61F2/2412), and in particular for an orthogonally delivered transcatheter prosthetic heart valve having a annular support frame having compressible wire cells that facilitate rolling and folding the valve length-wise, or orthogonally to the central axis of the flow control component, allowing a very large diameter valve to be delivered and deployed to the tricuspid valve from the inferior vena cava or superior vena cava, or trans-atrially to the mitral valve, the valve having a height of about 5-60 mm and a diameter of about 25-80 mm, without requiring an oversized diameter catheter and without requiring delivery and deployment from a catheter at an acute angle of approach.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of International Patent ApplicationSerial No. PCT/US2020/031390, filed May 4, 2020, entitled “Cinch Deviceand Method for Deployment of a Side-Delivered Prosthetic Heart Valve ina Native Annulus,” which claims priority to and the benefit of U.S.Provisional Application Ser. No. 62/843,424, filed May 4, 2019, entitled“Cinch Device and Method for Deployment of Orthogonal Prosthetic HeartValve in a Native Annulus,” the disclosure of each of which isincorporated herein by reference in its entirety.

BACKGROUND

Embodiments are described herein that relate to prosthetic heart valves,and in particular to a cinch device and method for deployment of anorthogonal prosthetic heart valve in a native annulus.

Prosthetic heart valves can pose challenges for delivery and deploymentwithin a heart, particularly for delivery by catheters through thepatient's vasculature rather than through a surgical approach. Deliveryof traditional transcatheter prosthetic valves generally includescompressing the valve in a radial direction and loading the valve into adelivery catheter such that a central annular axis of the valve isparallel to the lengthwise axis of the delivery catheter. The valves aredeployed from the end of the delivery catheter and expanded outwardly ina radial direction from the central annular axis. The expanded size(e.g., diameter) of traditional valves, however, can be limited by theinternal diameter of the delivery catheter. The competing interest ofminimizing delivery catheter size presents challenges to increasing theexpanded diameter of traditional valves (e.g., trying to compress toomuch material and structure into too little space).

Accordingly, a need exists for prosthetic valves with one or moredeployment-assistive features while maintaining a relatively smallcompressed size that allows for transcatheter delivery of the valve.

SUMMARY

The present invention is directed to a cinching apparatus to reduce thecircumference of the trans-annular sidewall of a valve duringdeployment, followed by release of the cinching apparatus to expand thecircumference to full size and obtain a secure sealing of the nativeannulus for a transcatheter heart valve replacement, the valve having aproximal sub-annular anchoring tab and a distal sub-annular anchoringtab, and in particular a side-delivered (length-wise) transcatheterprosthetic heart valve having a annular support frame havingcompressible wire cells that facilitate rolling, folding, compressing inheight and/or width, the valve length-wise, or orthogonal, to thecentral axis of the flow control component, allowing a very largediameter valve to be delivered and deployed from the inferior vena cavadirectly into the tricuspid valve, e.g., has a height of about 5-60 mmand a diameter of about 25-80 mm, without requiring an oversizeddiameter catheter and without requiring delivery and deployment from acatheter at an acute angle of approach.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross-sectional side view according to anembodiment.

FIG. 2 is a schematic bottom view according to an embodiment.

FIG. 3 is an image of one embodiment of the present invention, withcinching assembly attached to the orthogonally deliverable valve.

FIG. 4 is a schematic cross-sectional side view according to a distalend tether assembly embodiment.

FIG. 5 is an image of one embodiment of the present invention, withcinching assembly attached to the orthogonally deliverable valve.

FIG. 6 is an illustration of one embodiment of a valve prior tocinching, with proximal side blocked in a supra-annular (atrial)position, and distal side partially seated onto the annular ring withdistal subannular (ventricular) tab and distal atrial cuff formingdistal concave circumferential channel in the valve perimeter wall.

FIG. 7 is an illustration of one embodiment of a valve during cinching,with proximal side cinched or temporarily retracted inwards to allow theproximal side of the valve to be inserted down into the valve annulus,such that by shoe-horning (or adapting) the proximal side into theannulus, the proximal side can be released to move it from asupra-annular position to an annular position, and provide a tension fitagainst the annular ring. Distal side is shown partially seated onto theannular ring with distal subannular (ventricular) tab and distal atrialcuff forming distal concave circumferential channel in the valveperimeter wall.

FIG. 8 is an illustration showing one non-limiting embodiment of acinching system as step 1 of 3 in a released position, whereby thepulling tether and the attached pulling loop has snared the atrialportion (above the valve collar) of the cinching tether, while cinchingtether is strung through an eyelet in the collar between a lowermounting element attached to the perimeter wall below the collar and anupper mounting element, that is shown as a cinching loop that isfastened to an anchored steerable catheter where the steerable catheteris threaded through the cinching loop.

FIG. 9 is an illustration showing one non-limiting embodiment of acinching system as step 2 of 3 in a cinched position, whereby thepulling tether and the attached pulling loop has snared and pulled theatrial portion (above the valve collar) of the cinching tether, with thelower portion (below collar) of the cinching tether fore-shortened andpulling the valve frame perimeter wall to a (body) compressed position,with cinching tether strung through an eyelet in the collar between alower mounting element attached to the perimeter wall below the collarand an upper mounting element, that is shown as a cinching loop that isfastened to an anchored steerable catheter where the steerable catheteris threaded through the cinching loop.

FIG. 10 is an illustration showing one non-limiting embodiment of acinching system as step 3 of 3 back to a released position, whereby thevalve has been seated into the native annulus by lowering thecinched/compressed proximal side perimeter wall into the annular ringand releasing the cinch system to expand the perimeter wall against theproximal side of the native annulus.

FIG. 11 is an illustration showing one non-limiting embodiment of acinching system showing the steerable catheter being actuated (rotated,unscrewed) to disengage from the (threaded) receiver.

FIG. 12 is an illustration showing one non-limiting embodiment of acinching system and shows the steerable catheter pulled out of thecinching loop/eyelet of the cinching tether, with the steerable catheterbeing entirely withdrawn back into a delivery catheter and out of thepatient.

FIG. 13 is an illustration showing one non-limiting embodiment of acinching system and shows the pulling tether and its loop pulled out ofthe cinching loop/eyelet of the cinching tether, with the pulling tetherbeing entirely withdrawn back into a delivery catheter and out of thepatient.

FIG. 14 is another illustration showing one non-limiting embodiment of acinching system and shows the steerable catheter and the pulling tetherand its loop pulled out of the cinching loop/eyelet of the cinchingtether, with the steerable catheter and the pulling tether beingentirely withdrawn back into a delivery catheter and out of the patient.

FIG. 15 is an illustration of the deployed/seated valve with cinchingtether either available to be trimmed off, or left in place to besubsumed into the in-growth tissue.

FIG. 16 is an illustration showing one non-limiting embodiment of step 1of 4 of a delivery process for an orthogonally delivered prostheticheart valve having a distal anchoring tab/tension arm placed into adistal subannular position with distal perimeter wall wedged onto thenative annular ring, a folded/stowed proximal tab attached to a proximaltab catheter, and a cinching system installed onto the valve.

FIG. 17 is an illustration showing one non-limiting embodiment of step 2of 4 of a delivery process for an orthogonally delivered prostheticheart valve and shows the proximal side of the valve body (perimeterwall) cinched/retracted inwards to reduce the size (diameter,circumference) of the valve body so the valve can be seated into thenative annulus.

FIG. 18 is an illustration showing one non-limiting embodiment of step 3of 4 of a delivery process for an orthogonally delivered prostheticheart valve and shows both the release of the cinch, and the deploymentof the proximal tab, with cinching system releasing the compressiveforce on the valve body and allowing the valve to expand radially intothe native annulus, and with the proximal tab catheter unfolding thefolded/stowed proximal tab away from the valve body to provide aproximal side anchoring element for the valve.

FIG. 19 is an illustration showing one non-limiting embodiment of step 4of 4 of a delivery process for an orthogonally delivered prostheticheart valve where the valve has been deployed and the cinching systemand the proximal tab catheter are being withdrawn into the deliverycatheter and out of the patient.

FIG. 20 is an illustration showing step 1 of 2 of one non-limitingpreferred twisting embodiment of a cinching system, with the valve in anexpanded configuration, and a steerable catheter connected to multiplepulling and cinching (combination) tethers, with each tether strungthrough separate eyelets in the collar and mounted below the collar ofthe valve onto the valve body wall, where rotation of the steerablecatheter fore-shortens the tethers and twists or wrings the valve bodyto a narrower radial size to facilitate insertion and positioning intothe native annulus.

FIG. 21 is an illustration showing step 2 of 2 of one non-limitingpreferred twisting embodiment of a cinching system, with the valve in anradially compressed configuration, where rotation of the steerablecatheter has fore-shortened the tethers thereby twisting or wringing thevalve body to a narrower radial size to facilitate insertion andpositioning of the valve into the native annulus.

FIG. 22 is an illustration showing step 1 of 2 of one non-limitingpreferred belted embodiment of a cinching system, with the valve in anexpanded configuration, and a steerable catheter connected to rollercylinder, with a cinchable belt encircling the valve body and mountedbelow the collar of the valve onto the valve body wall, where rotationof the steerable catheter rotates the roller cylinder and fore-shortensthe cinchable belt to reduce the valve body to a narrower radial size tofacilitate insertion and positioning into the native annulus.

FIG. 23 is an illustration showing step 2 of 2 of one non-limitingpreferred cinchable belt embodiment of a cinching system, with the valvein an radially compressed configuration, where rotation of the steerablecatheter has rolled a portion of the belt onto the roller cylinder, andhas fore-shortened the belt reducing the valve body to a narrower radialsize to facilitate insertion and positioning of the valve into thenative annulus.

FIG. 24 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve with distal right ventricularoutflow tract (RVOT) tab, a proximal tab according to the invention.

FIG. 25 is an illustration of a side view of a single tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock.

FIG. 26 is an illustration of a side view of a double tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock.

FIG. 27 is an illustration of a side view of a double tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock, and to the foldedup proximal tab.

FIG. 28 is an illustration of a side view of a single tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock, and to the foldedup proximal tab.

FIG. 29 is a top view illustration of a valve in a cinchedconfiguration.

FIG. 30 is a top view illustration of a valve in an expandedconfiguration.

FIG. 31 is a top view illustration of a valve in a double sided cinchedconfiguration (septal and anterior, both cinched).

FIG. 32 is a top view illustration of a valve having the tetherinstalled, in a double sided expanded configuration (septal andanterior, both expanded).

FIG. 33 is a top view illustration of a valve having the tetherinstalled, in a double sided cinched configuration (septal and anterior,both cinched).

FIG. 34 is a chart showing the percentage reduction of the long-axis R1of the ellipse of the valve and the calculated shrinkage of thecircumference.

FIG. 35 is a chart showing the percentage reduction of the short-axis r1of the ellipse of the valve and the calculated shrinkage of thecircumference.

FIG. 36 is a chart showing the percentage reduction of the long-axis R1of the ellipse of the valve and the calculated shrinkage of thecircumference.

FIG. 37 is a top (nadir) view of the heart in cross section and show therelationship between the various anatomical features.

FIGS. 38A to 38D illustrate a valve delivery catheter working inconjunction with a cinching apparatus catheter to deliver the valve tothe native annulus, and then to release/uncinch the valve to effectuatea good seal simultaneous with more predictable seating of the valve inthe annulus.

FIG. 39 is an illustration of one type of wire frame panel showing awire frame configuration that is balanced between horizontal compressionand lateral compression.

FIG. 40 is an illustration of one type of wire frame panel showing awire frame configuration that is weighted more towards horizontalcompression than lateral compression.

FIG. 41 is an illustration of a percutaneously delivered prosthetictricuspid valve via the femoral-vein.

FIG. 42 is an illustration of one type of wire frame panel showing awire frame configuration that is weighted more towards horizontalcompression than lateral compression.

FIG. 43 is an illustration of one type of wire frame panel showing awire frame configuration that is balanced between horizontal compressionand lateral compression.

FIG. 44 is an illustration of a valve cinched and being seated in thetricuspid valve annulus.

FIG. 45 is an illustration of a valve released after being cinched andseated in the tricuspid valve annulus

FIG. 46 is an illustration of a valve cinched and being seated in themitral valve annulus.

FIG. 47 is an illustration of a valve released after being cinched andseated in the mitral valve annulus.

FIG. 48 is an illustration of a side perspective view of an innerregurgitation control component with radio-opaque markers as part of anorthogonally deliverable transcatheter heart valve with a collapsibleflow control component mounted within the annular outer support frame,the collapsible (inner) flow control component having leaflet frame with2-4 flexible leaflets mounted thereon, the leaflet frame foldable alonga z-axis from a cylindrical configuration to a flattened cylinderconfiguration and compressible along a vertical axis (y-axis) to ashortened configuration, and the valve having a superelastic wire loopdistal tab and a superelastic wire loop proximal tab according to theinvention.

FIG. 49 is an illustration of a side perspective exploded view of anembodiment having an inner regurgitation control component withradio-opaque markers, three leaflet cusp or pockets mounted within afoldable and compressible inner wire frame, the inner is mounted withinan outer wire frame which has a collar component attachedcircumferentially at a top edge of the outer wire frame, a dual tabcomponent, and a mesh component, according to the invention.

FIG. 50 is an illustration of a side perspective exploded view of anembodiment having an inner regurgitation control component withradio-opaque markers, three leaflet cusp or pockets mounted within afoldable and compressible inner wire frame, the inner is mounted withinan outer wire frame which has a collar component attachedcircumferentially at a top edge of the outer wire frame, a pair ofintegrated, independent tab components, and a mesh component, accordingto the invention.

FIG. 51 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve in a folded configuration alongthe z-axis (front to back when viewed from the broader side) accordingto the invention.

FIG. 52 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve in a vertically compressedconfiguration according to the invention.

FIG. 53 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve partially loaded into a deliverycatheter, according to the invention.

DETAILED DESCRIPTION OF THE INVENTION

The invention is directed to cinching apparatus for reducing the size,distal to proximal, of the valve to facilitate deployment of the largeorthogonal valve into the native annulus, and then to release thecinched configuration and allow the valve to expand once positionedwithin the annulus to effectuate a secure sealing for a dual-tabtranscatheter heart valve replacement that is a low profile,orthogonally delivered implantable prosthetic heart valve having anring-shaped or annular support frame, an inner 2- or 3-panel sleeve, anelongated sub-annular distal anchoring tab extending into the rightventricular outflow tract, an elongated sub-annular proximal anchoringtab extending into the proximal sub-annular space, preferably betweenthe anterior and the posterior leaflets.

In some implementations, the embodiments described herein are directed aside-delivered transcatheter prosthetic heart valve having an integratedcinching apparatus, comprising: (a) a self-expanding annular supportframe, said annular support frame having a central channel and an outerperimeter wall circumscribing a central vertical axis in an expandedconfiguration, an atrial sealing collar is disposed around at least aportion of a top edge of the outer perimeter wall, said annular supportframe having a distal side and a proximal side; (b) an integratedcinching apparatus comprising an elongated tether or strap attached tothe annular support frame, the tether or strap actuated from a controlhandle of a steerable catheter to cinch or reduce the radial size of theproximal side of the annular support frame; (c) a flow control componentmounted within the annular support frame and configured to permit bloodflow in a first direction through an inflow end of the valve and blockblood flow in a second direction, opposite the first direction, throughan outflow end of the valve; (d) a subannular distal anchoring tab ortension arm is attached to a distal portion of the perimeter wall andextending away from the perimeter wall 10-40 mm; (e) a subannularproximal anchoring tab or tension arm attached to a proximal portion ofthe perimeter wall and extending away from the perimeter wall 5-20 mm;wherein the valve is compressible to a compressed configuration forintroduction into the body using a delivery catheter for implanting at adesired location in the body, said compressed configuration is orientedalong a horizontal axis at an intersecting angle of between 45-135degrees to the central vertical axis, and expandable to an expandedconfiguration having a horizontal axis at an intersecting angle ofbetween 45-135 degrees to the central vertical axis; wherein thehorizontal axis of the compressed configuration of the valve issubstantially parallel to a length-wise cylindrical axis of the deliverycatheter; wherein the valve has a height of about 5-60 mm and a diameterof about 25-80 mm.

Any of the prosthetic heart valves described herein can include anintegrated cinching apparatus that has two (2) or more tethers.

Any of the prosthetic heart valves described herein can include whereinthe integrated cinching apparatus comprises a single-pull tethermechanism, a double tether pulling system, a multiple tether twistingmechanism, or a belt cinching mechanism.

Any of the prosthetic heart valves described herein can include whereinthe tether is braided polyethylene, treated pericardial tissue, ePTFE,or nitinol.

Any of the prosthetic heart valves described herein can include whereinthe tether or strap has a tooth-portion and the releasing element hastooth-engaging releasable pawl element.

Any of the prosthetic heart valves described herein can include whereinthe first tether or strap is attached to a top portion of a septal sideof the perimeter wall, and the second tether or strap is attached to abottom portion of the septal side of the perimeter wall.

Any of the prosthetic heart valves described herein can include whereinthe tether or strap is releasably attached to the subannular proximalanchoring tab, and the proximal anchoring tab is configured to move froma folded up position against the perimeter wall to an expanded positionfolding away from the perimeter wall, wherein the proximal anchoring tabhas a tab anchoring element, and the tether or strap has a tab releasingelement that cooperates with the tab anchoring element to move theproximal anchoring tab from the folded up position to the expandedposition.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame is covered with a biocompatible material.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame is comprised of a plurality of compressiblewire cells having an orientation and cell geometry substantiallyorthogonal to the central vertical axis to minimize wire cell strainwhen the annular support frame is configured in a vertical compressedconfiguration, a rolled compressed configuration, or a folded compressedconfiguration.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame has a lower body portion and an upper collarportion, wherein the lower body portion in an expanded configurationforms a shape selected from a funnel, cylinder, flat cone, or circularhyperboloid.

Any of the prosthetic heart valves described herein can include whereinsaid annular support frame is comprised of a braided, wire, or laser-cutwire frame, and said annular support frame is covered with abiocompatible material.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame has a side profile of a flat cone shape havinga diameter R of 40-80 mm, a diameter r of 20-60 mm, and a height of 5-60mm.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame has an inner surface and an outer surface,said inner surface and said outer surface covered with a biocompatiblematerial selected from the following consisting of: the inner surfacecovered with pericardial tissue, the outer surface covered with a wovensynthetic polyester material, and both the inner surface covered withpericardial tissue and the outer surface covered with a woven syntheticpolyester material.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame has a side profile of an hourglass shapehaving a top diameter R1 of 40-80 mm, a bottom diameter R2 of 50-70 mm,an internal diameter r of 20-60 mm, and a height of 5-60 mm.

Any of the prosthetic heart valves described herein can include whereinthe valve in an expanded configuration has a central vertical axis thatis substantially parallel to the first direction.

Any of the prosthetic heart valves described herein can include whereinthe flow control component has an internal diameter of 20-40 mm, and aplurality of leaflets of pericardial material joined to forma roundedcylinder at an inflow end and having a flat closable aperture at anoutflow end.

Any of the prosthetic heart valves described herein can include whereinthe flow control component is supported with one or more longitudinalsupports integrated into or mounted upon the flow control component, theone or more longitudinal supports selected from rigid or semi-rigidposts, rigid or semi-rigid ribs, rigid or semi-rigid battens, rigid orsemi-rigid panels, and combinations thereof.

Any of the prosthetic heart valves described herein can include whereinthe subannular distal anchoring tab is comprised of wire loop, a wireframe, a laser cut frame, an integrated frame section, or a stent, andthe distal anchoring tab extends from about 20-40 mm away from thedistal side of the annular support frame.

Any of the prosthetic heart valves described herein can include whereinthe proximal anchoring tab is comprised of wire loop, a wire frame, alaser cut frame, an integrated frame section, or a stent, and theproximal anchoring tab extends from about 10-20 mm away from theproximal side of the annular support frame.

Any of the prosthetic heart valves described herein can include an upperdistal anchoring tab attached to a distal upper edge of the annularsupport frame, the upper distal anchoring tab comprised of wire loop, awire frame, a laser cut frame, an integrated frame section, or a stent,and extends from about 10-20 mm away from the annular support frame.

Any of the prosthetic heart valves described herein can include whereinat least one tissue anchor connected to the annular support frame forengaging native tissue.

Any of the prosthetic heart valves described herein can include whereinthe outer perimeter wall comprises a front wall portion that is a firstflat panel and a back wall portion that is a second flat panel, andwherein a proximal fold area and a distal fold area each comprise a sewnseam, a fabric panel, a rigid hinge, or a flexible fabric span withoutany wire cells.

Any of the prosthetic heart valves described herein can include whereinthe annular support frame is comprised of compressible wire cellsselected from the group consisting of braided-wire cells, laser-cut wirecells, photolithography produced wire cells, 3D printed wire cells, wirecells formed from intermittently connected single strand wires in a waveshape, a zig-zag shape, or spiral shape, and combinations thereof.

Any of the prosthetic heart valves described herein can include whereinthe invention provides a process for manufacturing an orthogonallydelivered transcatheter prosthetic heart valve frame, comprising: usingadditive or subtractive metal or metal-alloy manufacturing to produce aself-expanding annular support frame, said annular support frame havinga central channel and an outer perimeter wall circumscribing a centralvertical axis in an expanded configuration, an atrial sealing collar isdisposed around at least a portion of a top edge of the outer perimeterwall, said annular support frame having a distal side and a proximalside, an integrated cinching apparatus, a flow control component mountedwithin the annular support frame and configured to permit blood flow ina first direction through an inflow end of the valve and block bloodflow in a second direction, opposite the first direction, through anoutflow end of the valve, an integrated subannular anchor systemattached to the annular support frame, the anchor system comprising anelongated tether or strap attached at a distal end to a rigid loop, anda slidable locking element slidably attached to the elongated tether orstrap, a distal anchoring tab mounted on the distal side of the annularsupport frame, a proximal anchoring tab mounted on the proximal side ofthe annular support frame, wherein the valve is compressible to acompressed configuration for introduction into the body using a deliverycatheter for implanting at a desired location in the body, saidcompressed configuration is oriented along a horizontal axis at anintersecting angle of between 45-135 degrees to the central verticalaxis, and expandable to an expanded configuration having a horizontalaxis at an intersecting angle of between 45-135 degrees to the centralvertical axis, wherein the horizontal axis of the compressedconfiguration of the valve is substantially parallel to a length-wisecylindrical axis of the delivery catheter, wherein the valve has aheight of about 5-60 mm and a diameter of about 25-80 mm, wherein theadditive metal or metal-alloy manufacturing is 3D printing or directmetal laser sintering (powder melt), and wherein the subtractive metalor metal-alloy manufacturing is photolithography, lasersintering/cutting, cnc machining, electrical discharge machining.

Any of the prosthetic heart valves described herein can include furthersteps of: (ii) mounting a flow control component within the valve frame,said flow control component configured to permit blood flow along thecentral vertical axis through an inflow end of the flow controlcomponent and block blood flow through an outflow end of the valve,(iii) covering an outer surface of the valve frame with a pericardiummaterial or similar biocompatible material.

Any of the method for compressing an implantable prosthetic heart valvefor length-wise orthogonal release of the valve from a deliverycatheter, can include the steps: flattening, rolling or folding theimplantable prosthetic heart valve into a compressed configurationwherein the long-axis of the compressed configuration of the valve issubstantially parallel to a length-wise cylindrical axis of the deliverycatheter, wherein the implantable prosthetic heart valve comprises anannular support frame having a flow control component mounted within theannular support frame and configured to permit blood flow in a firstdirection through an inflow end of the valve and block blood flow in asecond direction, opposite the first direction, through an outflow endof the valve, an integrated cinching system attached to the annularsupport frame, a distal anchoring tab mounted on a distal side of theannular support frame, a proximal anchoring tab mounted on a proximalside of the annular support frame, wherein the valve has a height ofabout 5-60 mm and a diameter of about 25-80 mm.

In another preferred embodiment, wherein the implantable prostheticheart valve is rolled or folded into a compressed configuration using astep selected from the group consisting of: unilaterally rolling into acompressed configuration from one side of the annular support frame;bilaterally rolling into a compressed configuration from two opposingsides of the annular support frame; flattening the annular support frameinto two parallel panels that are substantially parallel to thelong-axis, and then rolling the flattened annular support frame into acompressed configuration; and flattening the annular support frame alonga vertical axis to reduce a vertical dimension of the valve from top tobottom.

In another preferred embodiment, method for orthogonal delivery ofimplantable prosthetic heart valve to a desired location in the body,the method can comprise the step: advancing a delivery catheter to thedesired location in the body and delivering an expandable prostheticheart valve to the desired location in the body by releasing the valvefrom the delivery catheter, wherein the valve comprises a self-expandingannular support frame, said annular support frame having a centralchannel and an outer perimeter wall circumscribing a central verticalaxis in an expanded configuration, an atrial sealing collar is disposedaround at least a portion of a top edge of the outer perimeter wall,said annular support frame having a distal side and a proximal side, anintegrated cinching apparatus; a flow control component mounted withinthe annular support frame and configured to permit blood flow in a firstdirection through an inflow end of the valve and block blood flow in asecond direction, opposite the first direction, through an outflow endof the valve, a distal anchoring tab mounted on a distal side of theannular support frame, and a proximal anchoring tab mounted on aproximal side of the annular support frame, wherein said valve iscinchable to a cinched configuration having an elliptical circumferencefrom 5-30% reduced from an expanded configuration, or having a cinchedconfiguration where a long-axis of the top edge is reduced 5-30% indiameter, wherein the valve is compressible to a compressedconfiguration having a height of 5-10 mm and a width of 5-10 mm forintroduction into the body using a delivery catheter for implanting at adesired location in the body, said compressed configuration having along-axis oriented at an intersecting angle of between 45-135 degrees tothe first direction, and expandable to an expanded configuration havinga long-axis oriented at an intersecting angle of between 45-135 degreesto the first direction, wherein the long-axis of the compressedconfiguration of the valve is substantially parallel to a length-wisecylindrical axis of the delivery catheter, wherein the valve has aheight of about 5-60 mm and a diameter of about 25-80 mm.

The embodiments herein and the various features and advantageous detailsthereof are explained more fully with reference to the non-limitingembodiments that are illustrated in the accompanying drawings anddetailed in the following description. Descriptions of well-knowncomponents and processing techniques are omitted so as to notunnecessarily obscure the embodiments herein. The examples used hereinare intended merely to facilitate an understanding of ways in which theembodiments herein may be practiced and to further enable those of skillin the art to practice the embodiments herein. Accordingly, the examplesshould not be construed as limiting the scope of the embodiments herein.

Rather, these embodiments are provided so that this disclosure will bethorough and complete, and will fully convey the scope of the inventionto those skilled in the art. Like numbers refer to like elementsthroughout. As used herein the term “and/or” includes any and allcombinations of one or more of the associated listed items.

The terminology used herein is for the purpose of describing particularembodiments only and is not intended to limit the full scope of theinvention. As used herein, the singular forms “a,” “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, integers, steps, operations,elements, and/or components, but do not preclude the presence oraddition of one or more other features, integers, steps, operations,elements, components, and/or groups thereof.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art. Nothing in this disclosure is to be construed as anadmission that the embodiments described in this disclosure are notentitled to antedate such disclosure by virtue of prior invention. Asused in this document, the term “comprising” means “including, but notlimited to.”

Many modifications and variations can be made without departing from itsspirit and scope, as will be apparent to those skilled in the art.Functionally equivalent methods and apparatuses within the scope of thedisclosure, in addition to those enumerated herein, will be apparent tothose skilled in the art from the foregoing descriptions. Suchmodifications and variations are intended to fall within the scope ofthe appended claims. The present disclosure is to be limited only by theterms of the appended claims, along with the full scope of equivalentsto which such claims are entitled. It is to be understood that thisdisclosure is not limited to particular methods, reagents, compounds,compositions or biological systems, which can, of course, vary. It isalso to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting.

With respect to the use of substantially any plural and/or singularterms herein, those having skill in the art can translate from theplural to the singular and/or from the singular to the plural as isappropriate to the context and/or application. The varioussingular/plural permutations may be expressly set forth herein for sakeof clarity.

It will be understood by those within the art that, in general, termsused herein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art thatvirtually any disjunctive word and/or phrase presenting two or morealternative terms, whether in the description, claims, or drawings,should be understood to contemplate the possibilities of including oneof the terms, either of the terms, or both terms. For example, thephrase “A or B” will be understood to include the possibilities of “A”or “B” or “A and B.”

In addition, where features or aspects of the disclosure are describedin terms of Markush Groups, those skilled in the art will recognize thatthe disclosure is also thereby described in terms of any individualmember or subgroup of members of the Markush Group.

As will be understood by one skilled in the art, for any and allpurposes, such as in terms of providing a written description, allranges disclosed herein also encompass any and all possible subrangesand combinations of subranges thereof. Any listed range can be easilyrecognized as sufficiently describing and enabling the same range beingbroken down into at least equal subparts.

As will be understood by one skilled in the art, a range includes eachindividual member.

Definitions

Integrated Cinching Apparatus

In the description and claims herein, the term “integrated cinchingapparatus,” “cinch,” is used to describe an elongated tether that isattached to the frame of the valve in such a way that pulling on thetether will fold/bunch/curve the perimeter wall of the annular supportframe thus reducing the circumference of the entire valve, making iteasier to deploy the valve into the native annulus. The tether isattached to (exterior) or extends through (interior) the body/perimeterwall and/or collar portion of the prosthetic valve. The cinch apparatusmay have, in a preferred embodiment, a radio-opaque marker orradio-opaque material or structure so that a delivery system cathetercan be guided through the body of a patient to the site where the valveis mounted or to be mounted. In one preferred embodiment, delivery of anorthogonal valve is (length-wise delivery, height- andwidth-compression) through the femoral vein to the inferior vena cava(IVC) to the right atrium of the heart for anchoring the prosthetictricuspid heart valve replacement, followed by IVC delivery of theanchoring system to install the subannular anchors.

Side-Delivered, Side-Delivery, or Orthogonal

In the description and claims herein, the terms “side-delivered,”“side-delivery,” or “orthogonal” are used to describe that the valves ofthe present invention are compressed and delivered at a roughly 90degree angle compared to traditional transcatheter heart valves.Traditional valves have a central cylinder axis that is parallel to thelength-wise axis of the delivery catheter and are deployed from the endof the delivery catheter in a manner akin to pushing a closed umbrellaout of a sleeve. The valves of the present invention are compressed anddelivered in a sideways manner. Traditional valves can only be expandedas large as what the internal diameter of the delivery catheter willallow. Efforts to increase the expanded diameter of traditional valveshave run into the problems of trying to compress too much material andstructure into too little space. Mathematically, the term orthogonalrefers to an intersecting angle of 90 degrees between two lines orplanes. As used, herein the term “substantially orthogonal” refers to anintersecting angle ranging from 75 to 105 degrees. The intersectingangle or orthogonal angle refers to both (i) the relationship betweenthe length-wise cylindrical axis of the delivery catheter and thelong-axis of the compressed valve of the invention, where the long-axisis perpendicular to the central cylinder axis of traditional valves, and(ii) the relationship between the long-axis of the compressed orexpanded valve of the invention and the axis defined by the blood flowthrough the prosthetic heart valve where the blood is flowing, e.g.,from one part of the body or chamber of the heart to another downstreampart of the body or chamber of the heart, such as from an atrium to aventricle through a native annulus.

Transcatheter

In the description and claims herein, the term “transcatheter” is usedto define the process of accessing, controlling, and delivering amedical device or instrument within the lumen of a catheter that isdeployed into a heart chamber, as well as an item that has beendelivered or controlled by such as process. Transcatheter access isknown to include via femoral artery and femoral vein, via brachialartery and vein, via carotid and jugular, via intercostal (rib) space,and via sub-xyphoid. Transcatheter can be synonymous with transluminaland is functionally related to the term “percutaneous” as it relates todelivery of heart valves.

In preferred embodiments of the invention, the transcatheter approachincludes (i) advancing to the tricuspid valve or pulmonary artery of theheart through the inferior vena cava via the femoral vein, (ii)advancing to the tricuspid valve or pulmonary artery of the heartthrough the superior vena cava via the jugular vein, (iii) advancing tothe mitral valve of the heart through a trans-atrial approach, e.g.,Fossa ovalis or lower, via the IVC-femoral or the SVC-jugular approach.

Annular Support Frame

In the description and claims herein, the term “annular support frame,”and also “wire frame” or “flange or “collar” refers to athree-dimensional structural component that is seated within a nativevalve annulus and is used as a mounting element for a leaflet structure,a flow control component, or a flexible reciprocating sleeve orsleeve-valve.

In a preferred embodiment, the annular support frame is a self-expandingannular support frame, having a central channel and an outer perimeterwall circumscribing a central vertical axis in an expandedconfiguration. The perimeter wall encompasses both the collar and thelower body portions.

The perimeter wall can be further defined as having a front wall portionand a back wall portion, which are connected along a near side (to theIVC) or proximal side to a proximal fold area, and connected along a faror distal side to a distal fold area.

This front wall portion can be further defined as having a front uppercollar portion and a front lower body portion, and the back wall portioncan be further defined as having a back upper collar portion and a backlower body portion.

The annular support frame has a flow control component mounted withinthe annular support frame and configured to permit blood flow in a firstdirection through an inflow end of the valve and block blood flow in asecond direction, opposite the first direction, through an outflow endof the valve.

Since the frame is preferably made of superelastic metal or alloy suchas nitinol, the frame is compressible. Preferably, the frame isconstructed of a plurality of compressible wire cells having anorientation and cell geometry substantially orthogonal to the centralvertical axis to minimize wire cell strain when the annular supportframe when configured in a vertical compressed configuration, a rolledcompressed configuration, or a folded compressed configuration.

Annular Support Frame Structure

The annular support frame can be a ring, or cylindrical or conical tube,made from a durable, biocompatible structural material such as nitinolor similar alloy, wherein the annular support frame is formed bymanufacturing the structural material as a braided wire frame, alaser-cut wire frame, or a wire loop. The annular support frame is about5-60 mm in height, has an outer diameter dimension, R, of 30-80 mm, andan inner diameter dimension of 31-79 mm, accounting for the thickness ofthe wire material itself. As stated, the annular support frame can havea side-profile of a ring shape, cylinder shape, conical tube shape, butmay also have a side profile of a flat-cone shape, an inverted flat-coneshape (narrower at top, wider at bottom), a concave cylinder (walls bentin), a convex cylinder (walls bulging out), an angular hourglass, acurved, graduated hourglass, a ring or cylinder having a flared top,flared bottom, or both. In one preferred embodiment, the annular supportframe used in the prosthetic heart valve deployed in the tricuspidannulus may have a complex shape determined by the anatomical structureswhere the valve is being mounted. For example, in the tricuspid annulus,the circumference of the tricuspid valve may be a rounded ellipse, theseptal wall is known to be substantially vertical, and the tricuspid isknown to enlarge in disease states along the anterior-posterior line.Accordingly, a prosthetic heart valve may start in a roughly tubularconfiguration, and be heat-shaped to provide an upper atrial cuff orflange for atrial sealing and a lower trans-annular tubular orcylindrical section having an hourglass cross-section for about 60-80%of the circumference to conform to the native annulus along theposterior and anterior annular segments while remaining substantiallyvertically flat along 20-40% of the annular circumference to conform tothe septal annular segment.

Annular Support Frame Covering

The annular support frame is optionally internally or externallycovered, partially or completely, with a biocompatible material such aspericardium. The annular support frame may also be optionally externallycovered, partially or completely, with a second biocompatible materialsuch as polyester or Dacron®.

Annular Support Frame Purpose

The annular support frame has a central axial lumen where a prostheticheart valve or flow-control structure, such as a reciprocatingcompressible sleeve, is mounted across the diameter of the lumen. Theannular support frame is also tensioned against the inner aspect of thenative annulus and provides structural patency to a weakened annularring.

Annular Support Frame Optional Collars

The annular support frame may optionally have a separate atrial collarattached to the upper (atrial) edge of the frame, for deploying on theatrial floor, that is used to direct blood from the atrium into thesleeve and to seal against blood leakage around the annular supportframe. The annular support frame may also optionally have a separateventricular collar attached to the lower (ventricular) edge of theframe, for deploying in the ventricle immediately below the nativeannulus that is used to prevent regurgitant leakage during systole, toprevent dislodging of the device during systole, to sandwich or compressthe native annulus or adjacent tissue against the atrial collar, andoptionally to attach to and support the sleeve/conduit.

Annular Support Frame Delivery

The annular support frame may be compressed for transcatheter deliveryand may be expandable as a self-expandable shape-memory element or usinga transcatheter expansion balloon. Some embodiments may have both anatrial collar and a ventricular collar, whereas other embodiments withinthe scope of the invention include prosthetic heart valves having eithera single atrial collar, a single ventricular collar, or having noadditional collar structure.

Frame Material

Preferably, the frame is made from a superelastic metal component, suchas laser-cut nitinol tube, or flat sheet or other similarly functioningmaterial such as braided wire. The material may be used for theframe/stent, for the collar, and/or for anchors. It is contemplated aswithin the scope of the invention to use other shape memory alloys, aswell as polymer composites including composites containing carbonnanotubes, carbon fibers, metal fibers, glass fibers, and polymerfibers. It is contemplated that the frame may be constructed as a braid,wire, or laser cut frame. Laser cut frames are preferably made fromnitinol, but also without limitation made from stainless steel, cobaltchromium, titanium, and other functionally equivalent metals and alloys.

One key aspect of the frame design is that it be compressible and whenreleased have the stated property that it returns to its original(uncompressed) shape. This requirement limits the potential materialselections to metals and plastics that have shape memory properties.With regards to metals, nitinol has been found to be especially usefulsince it can be processed to be austenitic, martensitic or superelastic. Martensitic and super elastic alloys can be processed todemonstrate the required mechanical behavior.

Annular Frame Anchor Elements

The cinching tether releasably attaches to the valve, and includes avariety of mechanisms for how the tether is actuated. In one embodiment,the end of the tether has a release device, and the remainder of thetether is threaded through guide holes or tubes mounted on the frame. Inanother embodiment, the tether is attached to multiple locations inorder to folded one or both sides of the valve (perimeter wall), eitherin one large bend, or in multiple smaller bends. In another embodiment,there can be more than one tether. For example, in one embodiment, theremight be two tethers on one side of the valve, only reducing one side.In another embodiment, there might a tethers on opposing sides of valve,e.g., septal and anterior, to shrink or collapse the circumference ofthe valve.

Laser Cut

One possible construction of the wire frame envisions the laser cuttingof a thin, isodiametric nitinol tube. The laser cuts form regularcutouts in the thin nitinol tube. In one preferred embodiment, thenitinol tube expands to form a three-dimensional structure formed fromdiamond-shaped cells. The structure may also have additional functionalelements, e.g., loops, anchors, etc. for attaching accessory componentssuch as biocompatible covers, tissue anchors, releasable deployment andretrieval control guides, knobs, attachments, rigging, and so forth.

Secondarily the tube is thermo-mechanically processed using industrystandard nitinol shape forming methods. The treatment of the wire framein this manner will form a device that has shape memory properties andwill readily revert to the memory shape once deployed.

Braided Wire

Another possible construction of the wire frame envisions utilizingsimple braiding techniques using a nitinol wire and a simple braidingfixture. The wire is wound on the braiding fixture in a pattern until anisodiametric tube is formed. Secondarily, the braided wire frame isplaced on a shaping fixture and processed using industry standardnitinol shape forming methods.

Flow Control Component

In the description and claims herein, the term “flow control component”refers in a non-limiting sense to a leaflet structure having 2-, 3-,4-leaflets of flexible biocompatible material such a treated oruntreated pericardium that is sewn or joined to a annular support frame,to function as a prosthetic heart valve. Such a valve can be a heartvalve, such as a tricuspid, mitral, aortic, or pulmonary, that is opento blood flowing during diastole from atrium to ventricle, and thatcloses from systolic ventricular pressure applied to the outer surface.Repeated opening and closing in sequence can be described as“reciprocating.” The flow control component is contemplated in avalve-in-valve embodiment to also include a wide variety of(bio)prosthetic artificial heart valves, including ball valves (e.g.,Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g.,Bjork-Shiley), stented pericardium heart-valve prosthesis' (bovine,porcine, ovine) (Edwards line of bioprostheses, St. Jude prostheticvalves), as well as homograft and autograft valves. Bioprostheticpericardial valves can include bioprosthetic aortic valves,bioprosthetic mitral valves, bioprosthetic tricuspid valves, andbioprosthetic pulmonary valves.

Transcatheter

The term “transcatheter” is used to define the process of accessing,controlling, and/or delivering a medical device or instrument within thelumen of a catheter that is deployed into a heart chamber (or otherdesired location in the body), as well as an item that has beendelivered or controlled by such as process. Transcatheter access isknown to include cardiac access via the lumen of the femoral arteryand/or vein, via the lumen of the brachial artery and/or vein, via lumenof the carotid artery, via the lumen of the jugular vein, via theintercostal (rib) and/or sub-xiphoid space, and/or the like.Transcatheter can be synonymous with transluminal and is functionallyrelated to the term “percutaneous” as it relates to delivery of heartvalves. As used herein, the term “lumen” can refer to the inside of acylinder or tube. The term “bore” can refer to the inner diameter of thelumen.

Tissue Anchor

In the description and claims herein, the term “tissue anchor” or“plication tissue anchor” or “secondary tissue anchor,” or “dart” or“pin” refers to a fastening device that connects the upper atrial frameto the native annular tissue, usually at or near the periphery of thecollar. The anchor may be positioned to avoid piercing tissue and justrely on the compressive force of the two plate-like collars on thecaptured tissue, or the anchor, itself or with an integrated securementwire, may pierce through native tissue to provide anchoring, or acombination of both. The anchor may have a specialized securementmechanism, such as a pointed tip with a groove and flanged shoulder thatis inserted or popped into a mated aperture or an array of matedapertures that allow the anchor to attach, but prevent detachment whenthe aperture periphery locks into the groove near the flanged shoulder.The securement wire may be attached or anchored to the collar oppositethe pin by any attachment or anchoring mechanisms, including a knot, asuture, a wire crimp, a wire lock having a cam mechanism, orcombinations.

Support Post

The term “support post” refers to a rigid or semi-rigid length ofmaterial such as Nitinol or PEEK, that may be mounted on a spoked frameand that runs axially, or down the center of, or within a sewn seam of,the flexible sleeve. The sleeve may be unattached to the support post,or the sleeve may be directly or indirectly attached to the supportpost.

In the description that follows, the term “body channel” is used todefine a blood conduit or vessel within the body. Of course, theparticular application of the prosthetic heart valve determines the bodychannel at issue. An aortic valve replacement, for example, would beimplanted in, or adjacent to, the aortic annulus. Likewise, a tricuspidor mitral valve replacement will be implanted at the tricuspid or mitralannulus. Certain features of the present invention are particularlyadvantageous for one implantation site or the other. However, unless thecombination is structurally impossible, or excluded by claim language,any of the heart valve embodiments described herein could be implantedin any body channel.

The term “lumen” refers to the inside of the cylinder tube. The term“bore” refers to the inner diameter.

Displacement—the volume of fluid displaced by one complete stroke orrevolution.

Ejection fraction is a measurement of the percentage of blood leavingyour heart each time it contracts. During each heartbeat pumping cycle,the heart contracts and relaxes. When your heart contracts, it ejectsblood from the two pumping chambers (ventricles).

As a point of further definition, the term “expandable” is used hereinto refer to a component of the heart valve capable of expanding from afirst, delivery diameter to a second, implantation diameter. Anexpandable structure, therefore, does not mean one that might undergoslight expansion from a rise in temperature, or other such incidentalcause. Conversely, “non-expandable” should not be interpreted to meancompletely rigid or a dimensionally stable, as some slight expansion ofconventional “non-expandable” heart valves, for example, may beobserved.

Prosthetic Heart Valve

The term prosthesis or prosthetic encompasses both complete replacementof an anatomical part, e.g., a new mechanical valve replaces a nativevalve, as well as medical devices that take the place of and/or assist,repair, or improve existing anatomical parts, e.g., native valve is leftin place. For mounting within a passive assist cage, the inventioncontemplates a wide variety of (bio)prosthetic artificial heart valves.Contemplated as within the scope of the invention are ball valves (e.g.,Starr-Edwards), bileaflet valves (St. Jude), tilting disc valves (e.g.,Bjork-Shiley), stented pericardium heart-valve prosthesis (bovine,porcine, ovine) (Edwards line of bioprostheses, St. Jude prostheticheart valves), as well as homograft and autograft valves. Forbioprosthetic pericardial valves, it is contemplated to usebioprosthetic aortic valves, bioprosthetic mitral valves, bioprosthetictricuspid valves, and bioprosthetic pulmonary valves.

Tethers

The tethers are made from surgical-grade materials such as biocompatiblepolymer suture material. Non-limiting examples of such material includeultra-high-molecular weight polyethylene (UHMWPE), 2-0 exPFTE(polytetrafluoroethylene) or 2-0 polypropylene. In one embodiment thetethers are inelastic. It is also contemplated that one or more of thetethers may optionally be elastic to provide an even further degree ofcompliance of the valve during the cardiac cycle.

Tines—Anchors—Tines/Barbs

The device can be seated within the valvular annulus through the use oftines or barbs. These may be used in conjunction with, or in place ofone or more tethers. The tines or barbs are located to provideattachment to adjacent tissue. Tines are forced into the annular tissueby mechanical means such as using a balloon catheter. In onenon-limiting embodiment, the tines may optionally be semi-circular hooksthat upon expansion of the wire frame body, pierce, rotate into, andhold annular tissue securely. Anchors are deployed by over-wire deliveryof an anchor or anchors through a delivery catheter. The catheter mayhave multiple axial lumens for delivery of a variety of anchoring tools,including anchor setting tools, force application tools, hooks, snaringtools, cutting tools, radio-frequency and radiological visualizationtools and markers, and suture/thread manipulation tools. Once theanchor(s) are attached to the moderator band, tensioning tools may beused to adjust the length of tethers that connect to an implanted valveto adjust and secure the implant as necessary for proper functioning. Itis also contemplated that anchors may be spring-loaded and may havetether-attachment or tether-capture mechanisms built into the tetheringface of the anchor(s). Anchors may also have in-growth material, such aspolyester fibers, to promote in-growth of the anchors into themyocardium.

In one embodiment, where a prosthetic heart valve may or may not includea ventricular collar, the anchor or dart is not attached to a lowerventricular collar, but is attached directly into annular tissue orother tissue useful for anchoring.

Polymers

In some embodiments, components may be fabricated from a syntheticmaterial(s) such a polyurethane or polytetrafluoroethylene (PTFE). Wherea thin, durable synthetic material is contemplated (e.g., for acovering) synthetic polymer materials such expanded PTFE or polyestermay optionally be used. Other suitable materials may optionally includethermoplastic polycarbonate urethane, polyether urethane, segmentedpolyether urethane, silicone polyether urethane, polyetheretherketone(PEEK), silicone-polycarbonate urethane, polypropylene, polyethylene,low-density polyethylene, high-density polyethylene, and ultra-highmolecular weight polyethylene. Additional biocompatible polymers mayoptionally include elastomers, polyolefins, polyethylene-glycols,polyethersulphones, polysulphones, polyvinylpyrrolidones,polyvinylchlorides, other fluoropolymers, polyesters,polyethylene-terephthalate (PET) (e.g., Dacron®), Poly-L-lactic acids(PLLA), polyglycolic acid (PGA), poly(D, L-lactide/glycolide) copolymer(PDLA), silicone polyesters, polyamides (nylon), PTFE, elongated PTFE,expanded PTFE, polyurethanes, siloxane polymers and/or oligomers, and/orpolylactones, and block co-polymers using the same.

Components

In some embodiments, a valve frame and/or components thereof may befabricated from biocompatible metals, metal alloys, polymer coatedmetals, and/or the like. Suitable biocompatible metals and/or metalalloys can include stainless steel (e.g., 316L stainless steel), cobaltchromium (Co—Cr) alloys, nickel-titanium alloys (e.g., Nitinol®), and/orthe like. Suitable polymer coatings can include polyethylene vinylacetate (PEVA), poly-butyl methacrylate (PBMA), translute styreneisoprene butadiene (SIBs) copolymer, polylactic acid, polyester,polylactide, D-lactic polylactic acid (DLPLA), and/or the like.

Covering

Any of the valve frames and/or portions or components thereof can beinternally or externally covered, partially or completely, with abiocompatible material such as pericardium. A valve frame may also beoptionally externally covered, partially or completely, with a secondbiocompatible material such as polyester or Dacron®. Disclosedembodiments may use tissue, such as a biological tissue that is achemically stabilized pericardial tissue of an animal, such as a cow(bovine pericardium), sheep (ovine pericardium), pig (porcinepericardium), or horse (equine pericardium). Preferably, the tissue isbovine pericardial tissue. Examples of suitable tissue include that usedin the products Duraguard®, Peri-Guard®, and Vascu-Guard®, all productscurrently used in surgical procedures, and which are marketed as beingharvested generally from cattle less than 30 months old.

Covered Wire Frame Materials

Drug-eluting wire frames are contemplated for use herein. Des basicallyconsist of three parts: wire frame platform, coating, and drug. Some ofthe examples for polymer free des are amazon pax (MINVASYS) usingAmazonia CroCo (L605) cobalt chromium (Co—Cr) wire frame with Paclitaxelas an antiproliferative agent and abluminal coating have been utilizedas the carrier of the drug. BioFreedom (Biosensors Inc.) using stainlesssteel as base with modified abluminal coating as carrier surface for theantiproliferative drug Biolimus A9. Optima (CID S.r.I.) using 316Lstainless steel wire frame as base for the drug Tacrolimus and utilizingintegrated turbostratic carbofilm as the drug carrier. VESTA sync (MIVTherapeutics) using GenX stainless steel (316L) as base utilizingmicroporous hydroxyapatite coating as carrier for the drug Sirolimus.YUKON choice (Translumina) used 316L stainless steel as base for thedrugs Sirolimus in combination with Probucol.

Biosorbable polymers may also be used herein as a carrier matrix fordrugs. Cypher, Taxus, and Endeavour are the three basic type ofbioabsorbable DES. Cypher (J&J, Cordis) uses a 316L stainless steelcoated with polyethylene vinyl acetate (PEVA) and poly-butylmethacrylate (PBMA) for carrying the drug Sirolimus. Taxus (BostonScientific) utilizes 316L stainless steel wire frames coated withtranslute Styrene Isoprene Butadiene (SIBS) copolymer for carryingPaclitaxel which elutes over a period of about 90 days. Endeavour(Medtronic) uses a cobalt chrome driver wire frame for carryingZotarolimus with phosphorylcholine as drug carrier. BioMatrix employingS-Wire frame (316L) stainless steel as base with polylactic acid surfacefor carrying the antiproliferative drug Biolimus. ELIXIR-DES program(Elixir Medical Corp) consisting both polyester and polylactide coatedwire frames for carrying the drug Novolimus with cobalt-chromium (Co—Cr)as base. JACTAX (Boston Scientific Corp.) utilized D-lactic polylacticacid (DLPLA) coated (316L) stainless steel wire frames for carryingPaclitaxel. NEVO (Cordis Corporation, Johnson & Johnson) used cobaltchromium (Co—Cr) wire frame coated with polylactic-co-glycolic acid(PLGA) for carrying the drug Sirolimus.

Example

The transcatheter prosthetic heart valve may be percutaneously deliveredusing a transcatheter process via the femoral through the IVC, carotid,sub-xyphoid, intercostal access across the chest wall, and trans-septalto the mitral annulus through the fossa ovalis.

The device is delivered via catheter to the right or left atrium and isexpanded from a compressed shape that fits with the internal diameter ofthe catheter lumen. The compressed valve is loaded external to thepatient into the delivery catheter, and is then pushed out of thecatheter when the capsule arrives to the atrium. The cardiac treatmenttechnician visualizes this delivery using available imaging techniquessuch as fluoroscopy or ultrasound.

In a preferred embodiment the valve self-expands upon release from thecatheter since it is constructed in part from shape-memory material,such as Nitinol®, a nickel-titanium alloy, or a cobalt-chromium alloy,alloys used in biomedical implants.

In another embodiment, the valve may be constructed of materials thatrequires balloon-expansion after the capsule has been ejected from thecatheter into the atrium.

The atrial collar/frame and the flow control component are expanded totheir functional diameter, as they are deployed into the native annulus,providing a radial tensioning force to secure the valve. Once the frameis deployed about the tricuspid annulus, fasteners secure the deviceabout the native annulus. Additional fastening of the device to nativestructures may be performed, and the deployment is complete. Furtheradjustments using hemodynamic imaging techniques are contemplated aswithin the scope of the invention in order to ensure the device issecure, is located and oriented as planned, and is functioning as asubstitute or successor to the native tricuspid valve.

Example—Delivery Process

Orthogonal delivery steps: provide a foldable, compressible prosthetictricuspid valve, load the valve sideways into a delivery catheter,advance the valve to the heart via the IVC or the SVC over a pre-placedguidewire that is threaded onto a guidewire loop of a subannular distaltab, partially expel the valve to position the distal subannular tab, towedge the channel of the valve body against the distal annular ring,with the atrial collar disposed on a top surface of the annular tissueregion, and to allow the valve leaflets to begin functioning use acinching system to radially reduce the proximal side of the valve body,complete deployment of the valve by seating into the native annulus, andextend/unfold subannular proximal anchoring tab.

Example—Manufacturing Process

In a preferred embodiment the invention includes a process formanufacturing an orthogonally delivered transcatheter prosthetic heartvalve frame, comprising: (i) using additive or subtractive metal ormetal-alloy manufacturing to produce a self-expanding annular supportframe, wherein the additive metal or metal-alloy manufacturing is 3Dprinting or direct metal laser sintering (powder melt), and wherein thesubtractive metal or metal-alloy manufacturing is photolithography,laser sintering/cutting, CNC machining, electrical discharge machining.

In another preferred embodiment, there is provided a process formanufacturing an orthogonally delivered transcatheter prosthetic heartvalve frame, further comprising the steps of: (ii) mounting a flowcontrol component within the valve frame, said flow control componentconfigured to permit blood flow along the central vertical axis throughan inflow end of the flow control component and block blood flow throughan outflow end of the valve, (iii) covering an outer surface of thevalve frame with a pericardium material or similar biocompatiblematerial.

Example—Compression Methods

In another preferred embodiment, there is provided a method ofcompressing, wherein the implantable prosthetic heart valve is rolled orfolded into a compressed configuration using a step selected from thegroup consisting of: (i) unilaterally rolling into a compressedconfiguration from one side of the annular support frame; (i)bilaterally rolling into a compressed configuration from two opposingsides of the annular support frame; (iii) flattening the annular supportframe into two parallel panels that are substantially parallel to thelong-axis, and then rolling the flattened annular support frame into acompressed configuration; and (iv) flattening the annular support framealong a vertical axis to reduce a vertical dimension of the valve fromtop to bottom.

DRAWINGS

Referring now to the drawings, FIG. 1 is a schematic cross-sectionalside view according to an embodiment. FIG. 1 shows how the perimeter(circumference) of the lower transannular portion 106 of the valve 100can be cinched inward. This allows the valve to be designed with anover-sized transannular circumference, e.g., 5-20%, often 10-15%, topromote a tight fit of the valve within the native annulus and provide agood seal against perivalvular leakage (PVLs). The cinching processpulls the proximal sidewall inwards and reduces the circumference of thetransannular section 106. This allows the oversized valve to drop intothe native annulus during deployment of the valve. Then, once the valveis seated as desired, the transannular section is pushed back out to itsfull or nearly full, circumference, and thereby form a tight, sealed fitof the prosthetic valve in the native annulus.

FIG. 2 is a schematic bottom view according to an embodiment. FIG. 2shows a view from below and shows how the perimeter (circumference) ofthe lower transannular portion of the valve can be cinched inward, herethe proximal end of the transannular section of the valve. Thisover-sized transannular circumference, e.g., 5-20%, often 10-15%,promotes a tight fit of the valve within the native annulus and providesa good seal against perivalvular leakage (PVLs).

FIG. 3 is a schematic cross-sectional side view according to a proximaltether embodiment. FIG. 3 shows how the perimeter (circumference) of thelower transannular portion 106 of the valve 100 can be cinched inward.This allows the valve to be designed with an over-sized transannularcircumference, e.g., 5-20%, often 10-15%, to promote a tight fit of thevalve within the native annulus and provide a good seal againstperivalvular leakage (PVLs). Proximal end cinch tether 105 shows anon-limiting mechanism for performing the cinching process. Cinch tether105 travels from a delivery catheter (not shown) through way-guidecomponents such a eyelets 111. In this embodiment, the cinch tether 105travels through the collar 103 by way of the eyelets to the cinch tethermount on the proximal side 114 of the transannular section 106 of thelower part of the valve 100. Pulling the cinch tether proximally,towards the operator, pulls the proximal sidewall inwards and reducesthe circumference of the transannular section 106. This allows theoversized valve to drop into the native annulus during deployment of thevalve. Then, once the valve is seated as desired, the cinch tether 105can be advanced (or released if the transannular section isspring-biased into the folded configuration) to push the proximal side114 back out to its full or nearly full, circumference, and thereby forma tight, sealed fit of the prosthetic valve in the native annulus.

FIG. 4 is a schematic cross-sectional side view according to a distaltether embodiment. FIG. 4 shows how the perimeter (circumference) of thelower transannular portion 106 of the valve 100 can be cinched inward.This allows the valve to be designed with an over-sized transannularcircumference, e.g., 5-20%, often 10-15%, to promote a tight fit of thevalve within the native annulus and provide a good seal againstperivalvular leakage (PVLs). Distal end cinch tether 105 shows anon-limiting mechanism for performing the cinching process. Cinch tether105 travels from a delivery catheter (not shown) through way-guidecomponents such a eyelets 111. In this embodiment, the cinch tether 105travels through the collar 103 by way of the eyelets to the cinch tethermount on the proximal side 114 of the transannular section 106 of thelower part of the valve 100. Pulling the cinch tether proximally,towards the operator, pulls the proximal sidewall inwards and reducesthe circumference of the transannular section 106. This allows theoversized valve to drop into the native annulus during deployment of thevalve. Then, once the valve is seated as desired, the cinch tether 105can be advanced (or released if the transannular section isspring-biased into the folded configuration) to push the proximal side114 back out to its full or nearly full, circumference, and thereby forma tight, sealed fit of the prosthetic valve in the native annulus.

FIG. 5 is an image of one embodiment of the present invention, withcinching assembly attached to the orthogonally deliverable valve.

FIG. 5 shows valve having valve cuff/collar 103 circumscribing the topedge of cylindrical valve body, with valve leaflet 258 disposed in aflow control component 130 mounted within the axial lumen of the valvebody, and a pierceable seal mounted adjacent the flow control component.

FIG. 5 also shows a cinching system 105-107-111 exemplified in anon-limiting aspect with a steerable catheter/control cable 107extending from a transcatheter delivery catheter and temporarily mountedinto a receiver element in a distal portion of the collar 103. Thesteerable catheter is threaded through a cinching loop on a cinchingtether 105, and the cinching tether is strung through an eyelet 111 inthe collar 103 between the steerable catheter, and a tether mount 112 onthe valve body, with cinching tether loop disposed at an above-collar,atrial side position, and cinching tether mount 112 disposed below thecollar.

FIG. 5 shows that by pulling the pulling tether 105, it will apply aradially compressive, or cinching force on the valve body, so that,while the distal side is held against the annular ring, the proximalside can be positioned and lowered into the annular ring, and whenreleased, causes a tension fit of the valve into the annulus.

FIG. 5 also shows a proximal anchoring tab 270 attached to a proximaltab control catheter. The proximal anchoring tab starts in a folded orstowed configuration, and after the valve body has been shoe-horned intothe annulus, the proximal anchoring tab can be unfolded or released toextend away from the valve body and provide a subannular anchoring force(upward) on the proximal side. The upward force of the lower proximalanchor is balanced against the proximal side collar providing asupra-annular downward force. Similarly, on the distal side, the distalcollar (downward force, ventricular direction), and the distal anchoringtab (upward force, atrial direction), provide upper and lowersandwiching anchoring mechanisms for the valve.

FIG. 6 is an illustration of one embodiment of a valve prior tocinching, with proximal side blocked in a supra-annular (atrial)position, and distal side partially seated onto the annular ring withdistal subannular (ventricular) tab and distal atrial cuff formingdistal concave circumferential channel in the valve perimeter wall.

FIG. 7 is an illustration of one embodiment of a valve during cinching,with proximal side cinched or temporarily retracted inwards to allow theproximal side of the valve to be inserted down into the valve annulus,such that by shoe-horning (or adapting) the proximal side into theannulus, the proximal side can be released to move it from asupra-annular position to an annular position, and provide a tension fitagainst the annular ring. Distal side is shown partially seated onto theannular ring with distal subannular (ventricular) tab and distal atrialcuff forming distal concave circumferential channel in the valveperimeter wall.

FIG. 8 is an illustration showing one non-limiting embodiment of acinching system as step 1 of 3 in a released position, whereby thepulling tether and the attached pulling loop has snared the atrialportion (above the valve collar) of the cinching tether, while cinchingtether is strung through an eyelet in the collar between a lowermounting element attached to the perimeter wall below the collar and anupper mounting element, that is shown as a cinching loop that isfastened to an anchored steerable catheter where the steerable catheteris threaded through the cinching loop.

FIG. 9 is an illustration showing one non-limiting embodiment of acinching system as step 2 of 3 in a cinched position, whereby thepulling tether and the attached pulling loop has snared and pulled theatrial portion (above the valve collar) of the cinching tether, with thelower portion (below collar) of the cinching tether fore-shortened andpulling the valve frame perimeter wall to a (body) compressed position,with cinching tether strung through an eyelet in the collar between alower mounting element attached to the perimeter wall below the collarand an upper mounting element, that is shown as a cinching loop that isfastened to an anchored steerable catheter where the steerable catheteris threaded through the cinching loop.

FIG. 10 is an illustration showing one non-limiting embodiment of acinching system as step 3 of 3 back to a released position, whereby thevalve has been seated into the native annulus by lowering thecinched/compressed proximal side perimeter wall into the annular ringand releasing the cinch system to expand the perimeter wall against theproximal side of the native annulus.

FIG. 11 is an illustration showing one non-limiting embodiment of acinching system showing the steerable catheter being actuated (rotated,unscrewed) to disengage from the (threaded) receiver.

FIG. 12 is an illustration showing one non-limiting embodiment of acinching system and shows the steerable catheter pulled out of thecinching loop/eyelet of the cinching tether, with the steerable catheterbeing entirely withdrawn back into a delivery catheter and out of thepatient.

FIG. 13 is an illustration showing one non-limiting embodiment of acinching system and shows the pulling tether and its loop pulled out ofthe cinching loop/eyelet of the cinching tether, with the pulling tetherbeing entirely withdrawn back into a delivery catheter and out of thepatient.

FIG. 14 is another illustration showing one non-limiting embodiment of acinching system and shows the steerable catheter and the pulling tetherand its loop pulled out of the cinching loop/eyelet of the cinchingtether, with the steerable catheter and the pulling tether beingentirely withdrawn back into a delivery catheter and out of the patient.

FIG. 15 is an illustration of the deployed/seated valve with cinchingtether either available to be trimmed off, or left in place to besubsumed into the in-growth tissue.

FIG. 16 is an illustration showing one non-limiting embodiment of step 1of 4 of a delivery process for an orthogonally delivered prostheticheart valve having a distal anchoring tab/tension arm 258 placed into adistal subannular position with distal perimeter wall wedged onto thenative annular ring, a folded/stowed proximal tab 270 attached to aproximal tab catheter, and a cinching system 105-107-111-112 installedonto the valve.

FIG. 17 is an illustration showing one non-limiting embodiment of step 2of 4 of a delivery process for an orthogonally delivered prostheticheart valve and shows the proximal side of the valve body (perimeterwall) cinched/retracted inwards to reduce the size (diameter,circumference) of the valve body so the valve can be seated into thenative annulus.

FIG. 18 is an illustration showing one non-limiting embodiment of step 3of 4 of a delivery process for an orthogonally delivered prostheticheart valve and shows both the release of the cinch, and the deploymentof the proximal tab, with cinching system releasing the compressiveforce on the valve body and allowing the valve to expand radially intothe native annulus, and with the proximal tab catheter unfolding thefolded/stowed proximal tab away from the valve body to provide aproximal side anchoring element for the valve.

FIG. 19 is an illustration showing one non-limiting embodiment of step 4of 4 of a delivery process for an orthogonally delivered prostheticheart valve where the valve has been deployed and the cinching systemand the proximal tab catheter are being withdrawn into the deliverycatheter and out of the patient.

FIG. 20 is an illustration showing step 1 of 2 of one non-limitingpreferred twisting embodiment of a cinching system, with the valve in anexpanded configuration, and a steerable catheter connected to multiplepulling and cinching (combination) tethers, with each tether strungthrough separate eyelets in the collar and mounted below the collar ofthe valve onto the valve body wall, where rotation of the steerablecatheter fore-shortens the tethers and twists or wrings the valve bodyto a narrower radial size to facilitate insertion and positioning intothe native annulus.

FIG. 21 is an illustration showing step 2 of 2 of one non-limitingpreferred twisting embodiment of a cinching system, with the valve in anradially compressed configuration, where rotation of the steerablecatheter has fore-shortened the tethers thereby twisting or wringing thevalve body to a narrower radial size to facilitate insertion andpositioning of the valve into the native annulus.

FIG. 22 is an illustration showing step 1 of 2 of one non-limitingpreferred belted embodiment of a cinching system, with the valve in anexpanded configuration, and a steerable catheter connected to rollercylinder, with a cinchable belt encircling the valve body and mountedbelow the collar of the valve onto the valve body wall, where rotationof the steerable catheter rotates the roller cylinder and fore-shortensthe cinchable belt to reduce the valve body to a narrower radial size tofacilitate insertion and positioning into the native annulus.

FIG. 23 is an illustration showing step 2 of 2 of one non-limitingpreferred cinchable belt embodiment of a cinching system, with the valvein an radially compressed configuration, where rotation of the steerablecatheter has rolled a portion of the belt onto the roller cylinder, andhas fore-shortened the belt reducing the valve body to a narrower radialsize to facilitate insertion and positioning of the valve into thenative annulus.

FIG. 24 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve with distal right ventricularoutflow tract (RVOT) tab, a proximal tab according to the invention.

FIG. 25 is an illustration of a side view of a single tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock.

FIG. 26 is an illustration of a side view of a double tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock.

FIG. 27 is an illustration of a side view of a double tether cinchaccording to the invention having a delivery catheter sheathed overreleasable tether lock encircling the perimeter wall and anchormountable elements for connecting to the tether lock, and to the foldedup proximal tab.

FIG. 28 is a side view illustration of valve in a cinched configuration.

FIG. 29 is a top view illustration of a valve in a cinchedconfiguration.

FIG. 30 is a top view illustration of a valve in an expandedconfiguration.

FIG. 31 is a top view illustration of a valve in a double sided cinchedconfiguration (septal and anterior, both cinched).

FIG. 32 is a top view illustration of a valve having the tetherinstalled, in a double sided expanded configuration (septal andanterior, both expanded).

FIG. 33 is a top view illustration of a valve having the tetherinstalled, in a double sided cinched configuration (septal and anterior,both cinched).

FIG. 34 is a chart showing the percentage reduction of the long-axis R1of the ellipse of the valve and the calculated shrinkage of thecircumference.

FIG. 35 is a chart showing the percentage reduction of the short-axis r1of the ellipse of the valve and the calculated shrinkage of thecircumference.

FIG. 36 is a chart showing the percentage reduction of the long-axis R1of the ellipse of the valve and the calculated shrinkage of thecircumference.

FIG. 37 is a top (nadir) view of the heart in cross section and show therelationship between the various anatomical features.

FIGS. 38A to 38D illustrate a process of (FIG. 38A) a valve deliverycatheter working in conjunction with a cinching apparatus catheter todeliver the valve to the native annulus, (FIG. 38B) position a distalsubannular anchoring tab, and then (FIG. 38C) seat and release/uncinchthe valve to effectuate a good seal simultaneous with more predictableseating of the valve in the annulus, and then (FIG. 38D) extend theproximal subannular anchoring tab.

FIG. 39 is an illustration of one type of wire frame panel showing awire frame configuration that is balanced between horizontal compressionand lateral compression.

FIG. 40 is an illustration of one type of wire frame panel showing awire frame configuration that is weighted more towards horizontalcompression than lateral compression.

FIG. 41 is an illustration of a percutaneously delivered prosthetictricuspid valve via the femoral-vein.

FIG. 42 is an illustration of one type of wire frame panel showing awire frame configuration that is weighted more towards horizontalcompression than lateral compression.

FIG. 43 is an illustration of one type of wire frame panel showing awire frame configuration that is balanced between horizontal compressionand lateral compression.

FIG. 44 is an illustration of a valve 100 cinched and being seated inthe tricuspid valve annulus, with delivery catheter 138 accessingthrough the IVC.

FIG. 45 is an illustration of a valve 100 released after being cinchedand seated in the tricuspid valve annulus

FIG. 46 is an illustration of a valve 100 cinched and being seated inthe mitral valve annulus.

FIG. 47 is an illustration of a valve 100 released after being cinchedand seated in the mitral valve annulus, with delivery catheter 138accessing through the IVC via a trans-septal puncture.

Referring again to the drawings, FIG. 48 is an illustration of a sideperspective view of an orthogonally deliverable transcatheter heartvalve 100 with annular outer support frame 102, a collapsible flowcontrol component 130 mounted within the annular outer support frame102, distal tab 268 and proximal tab 270, according to the invention.FIG. 48 shows tether 105, control cable 107, and tether eyelet 111.Proximal wall 114 is shown here in an expanded configuration.

The inner regurgitation control component 135 is comprised of tissuecover 141, reinforcement ring 143, radiopaque markers 144, anddrum/regurgitation channel 135.

The collapsible (inner) flow control component 130 has leaflet frame 231with 2-4 flexible leaflets 258 mounted thereon, the leaflet frame 231foldable along a z-axis 109 from a cylindrical configuration to aflattened cylinder configuration and compressible along a vertical axis108 (y-axis) to a shortened configuration.

The annular outer support frame 102 is made from a shape-memory materialsuch as nickel-titanium alloy, for example nitinol, and is therefore aself-expanding structure starting from a compressed configuration. Theannular (outer) support frame 102 has a central (interior) channel andan outer perimeter wall 106 (transannular section) circumscribing acentral vertical axis 108, when in an expanded configuration, and saidannular outer support frame 102 having a distal side 118 and a proximalside 114.

The flow control component 130 is mounted within the annular outersupport frame 102 and is configured to permit blood flow in a firstdirection, e.g., atrial to ventricular, through an inflow end 132 of thevalve 100 and block blood flow in a second direction, opposite the firstdirection, through an outflow end 134 of the valve 100.

The inner regurgitation control component 135, like the inner flowcontrol component 130 and the outer annular frame 102, is foldable andcompressible. The inner flow control component 130 comprises leafletframe 231 with 2-4 flexible leaflets 258 mounted on the leaflet frame231.

The flow control component 130, and thereby the leaflet frame 231, likethe outer frame 102, is foldable along a z-axis (front to back) from acylindrical configuration to a flattened cylinder configuration, wherethe fold lines are located on a distal side and on a proximal side,taking the leaflet frame 231 from a ring or cylinder shape, andflattening it from a ring to a two-layer band i.e. Folded over onitself, or like a cylinder flattened into a rectangle or square joinedalong two opposing sides. This allows the outer frame 102 and the flowcontrol component 130 to reduce the radius along z-axis until the sidewalls are in contact or nearly so. This also allows the outer frame 102and the flow control component 130 to maintain the radius along thehorizontal axis, the y-axis, to minimize the number of wire cells, whichmake up the outer and the inner, that are damaged by forces appliedduring folding and/or compression necessary for loading into thedelivery catheter.

The inner regurgitation control component 135, flow control component130, leaflet frame 231, and the outer frame 102 are also vertically(y-axis) compressible, reducing the height of the entire valve structureto fit within the inner diameter of a delivery catheter 138 (not shownin this Figure). By folding in the z-axis and vertically compressing inthe y-axis, the valve structure is permitted to maintain a very largedimension along the horizontal, or x-axis. For example, a 60 mm orlarger diameter valve can be delivered via transcatheter techniques. Thelength of the long axis of a valve, e.g., 60 mm, since it runs parallelto the central axis of the delivery catheter, is not limited by thelarge amount of wire frame and cover material necessary for such a largevalve. This is not possible with existing center-axis delivery (axial)transcatheter valves. The use of a folded, compressed valve that isorthogonal to the traditional axial-delivery valves permits treatmentoptions not available previously. FIG. 48 also shows a distal anchoringtab 268 mounted on the distal side 118 of the annular outer supportframe 102, and a proximal anchoring tab 270 mounted on the proximal side114 of the annular outer support frame 102.

In a preferred embodiment, the horizontal x-axis of the valve is at anintersecting angle of between 45-135 degrees to the central verticaly-axis when in an expanded configuration.

In a preferred embodiment, the horizontal x-axis of the compressedconfiguration of the valve is substantially parallel to a length-wisecylindrical axis of the delivery catheter.

In another preferred embodiment, the valve has a height of about 5-60 mmand a diameter of about 25-80 mm. FIG. 48 also shows guide wire sheath310, and guide wire 311. Lumen or guide ball 266 is shown mounted on thedistal end of the distal tab 268 and having guide wire 311 threadedthrough the lumen 266. Lumen 266, although large enough in internaldiameter to permit the guide wire 311 to extend through, lumen 266 isnot large enough in internal diameter to permit the sheath 310 to extendthrough. This allows sheath 310 to be advanced along the guide wire 311until it runs up against the proximal side of the lumen 266, whereincontinued application of a pushing force on the sheath 310 pushesagainst the lumen, and allows the valve to be pulled by the distal tabout of the delivery catheter, and to the target location for deployingthe valve.

FIG. 49 is an illustration of a side perspective view of an explodedview of an embodiment having inner regurgitation drum 137 with markers144, channel 135, and ring 143. FIG. 49 also shows three leaflet 258cusps or pockets mounted within a foldable and compressible inner wireframe 231, with distal fold area 120 and proximal fold area 116, theinner 231 is mounted within an outer wire frame 102 which has a collarcomponent 103 attached circumferentially at a top edge 107 of the outerwire frame 102, a dual tab component having a distal (RVOT) tab 268 anda proximal tab 270, and an optional mesh component of biocompatiblematerial that may be used to cover the spacer element 137, to cover thecollar 103, to cover the inner and outer aspect of the outer frame 102,and/or to cover the anchoring tabs 268, and 270, according to theinvention.

Atrial collar 103 is shaped to conform to the native deploymentlocation. In a tricuspid replacement, the atrial collar will have a tallback wall portion to conform to the septal area of the native valve, andwill have a distal and proximal upper collar portion. The distal collarportion can be larger than the proximal upper collar portion to accountfor the larger flat space above (atrial) the right ventricular outflowtract (RVOT) subannular area.

FIG. 50 is an illustration of a side perspective view of an explodedview of an embodiment having an open regurgitation frame 139 havingradiopaque markers 144. FIG. 50 also shows three leaflet cusp or pockets258 mounted within a foldable and compressible inner wire frame 231, theinner 231 is mounted within an outer wire frame 102 which has a collarcomponent 103 attached circumferentially at a top edge 107 of the outerwire frame 102, an uncovered spacer 139, a pair of integrated,independent tab components 269, 270, and a mesh component 226, accordingto the invention.

Uncovered regurgitation frame 139 provides for controlled regurgitationof the valve. The uncovered regurgitation frame 139 can be later pluggedwith a later inserted stent or cover or plug, once regurgitation is nolonger needed by the patient.

Atrial collar 103 is shaped to conform to the native deploymentlocation. In a tricuspid replacement, the atrial collar will have a tallback wall portion to conform to the septal area of the native valve, andwill have a distal and proximal upper collar portion. The distal collarportion can be larger than the proximal upper collar portion to accountfor the larger flat space above (atrial) the right ventricular outflowtract (RVOT) subannular area.

Integrated tabs 269 and 271 are unitary construction with the body ofthe outer frame. The tabs may vary in size and shape. In a preferredembodiment, the RVOT tab, e.g., 269 may be longer to reach into theentry of the pulmonary artery (in the case of a tricuspid replacement).

FIG. 51 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve 100 in a folded configurationalong the z-axis (front to back when viewed from the broader side)according to the invention. FIG. 51 shows folded (flattened) outer frame102 with folded/flattened collar 103, hinge points 116, 120. FIG. 51also shows folded/flattened inner regurgitation control component 137with markers 144, and leaflets 258 mounted within folded/flattened innerframe 231.

FIG. 52 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve 100 in a vertically compressedconfiguration according to the invention. FIG. 52 shows outer frame 102folded (z-axis) and compressed vertically (y-axis) with collar 103folded (z-axis) and compressed (y-axis), along fold line between hingepoints 116, 120. FIG. 52 also shows inner regurgitation controlcomponent 137, and leaflets 258 mounted within inner frame 231.

FIG. 53 is an illustration of a side perspective view of an orthogonallydeliverable transcatheter heart valve 100 partially loaded into adelivery catheter 138, according to the invention. FIG. 53 shows outerframe 102, folded collar 103, inner regurgitation control component 137,and flow control component 130 having leaflets 258 and an inner frame231.

Various of the above-disclosed and other features and functions, oralternatives thereof, may be combined into many other different systemsor applications. Various presently unforeseen or unanticipatedalternatives, modifications, variations or improvements therein may besubsequently made by those skilled in the art, each of which is alsointended to be encompassed by the disclosed embodiments.

Having described embodiments for the invention herein, it is noted thatmodifications and variations can be made by persons skilled in the artin light of the above teachings. It is therefore to be understood thatchanges may be made in the particular embodiments of the inventiondisclosed which are within the scope and spirit of the invention asdefined by the appended claims. Having thus described the invention withthe details and particularity required by the patent laws, what isclaimed and desired protected by letters patent is set forth in theappended claims.

What is claimed:
 1. A prosthetic heart valve, comprising: a valve framedefining a central channel extending along a central axis of theprosthetic heart valve, the valve frame including a distal subannularanchoring element and a proximal subannular anchoring element; a flowcontrol component mounted within the central channel and configured topermit blood flow in a first direction along the central axis from aninflow end to an outflow end of the flow control component and blockblood flow in a second direction, opposite the first direction; and acinching system releasably coupled to the valve frame in at least onelocation, the prosthetic heart valve compressible along the central axisand a lateral axis perpendicular to the central axis to place theprosthetic heart valve in a compressed configuration to allowside-delivery of the prosthetic heart valve into a heart of a patientvia a delivery catheter, each of the central axis and the lateral axisbeing perpendicular to a longitudinal axis of the delivery catheter whenthe prosthetic heart valve is in the compressed configuration within thedelivery catheter, the prosthetic heart valve configured to transitionfrom the compressed configuration to an expanded configuration when theprosthetic heart valve is released from the delivery catheter, thecinching system actuatable when the prosthetic heart valve is in theexpanded configuration in the heart to transition at least one of thedistal subannular anchoring element or the proximal subannular anchoringelement from a first configuration to a second configuration to allowthe prosthetic heart valve to be seated in an annulus of a native heartvalve, the cinching system actuatable after the prosthetic heart valveis seated in the annulus to release the at least one of the distalsubannular anchoring element or the proximal subannular anchoringelement to the first configuration.
 2. The prosthetic heart valve ofclaim 1, wherein the prosthetic heart valve in the expandedconfiguration has a first height along the central axis and a firstlateral width along the lateral axis, and the prosthetic heart valve inthe compressed configuration has a second height along the central axisless than the first height and a second lateral width along the lateralaxis less than the first lateral width.
 3. The prosthetic heart valve ofclaim 2, wherein the prosthetic heart valve in the expandedconfiguration has a first longitudinal length along a longitudinal axisperpendicular to each of the central axis and the lateral axis, and theprosthetic heart valve in the compressed configuration has a secondlongitudinal length along the longitudinal axis greater than the firstlongitudinal length, the longitudinal axis of the prosthetic heart valvein the compressed configuration is parallel to the longitudinal axis ofthe delivery catheter when the prosthetic heart valve is within thedelivery catheter.
 4. The prosthetic heart valve of claim 3, wherein theprosthetic heart valve in the expanded configuration has the firstlongitudinal length along the longitudinal axis when the at least one ofthe distal subannular anchoring element or the proximal subannularanchoring element is in the first configuration, and the prostheticheart valve has a third longitudinal length along the longitudinal axisless than the first longitudinal length when the at least one of thedistal subannular anchoring element or the proximal subannular anchoringelement is in the second configuration.
 5. The prosthetic heart valve ofclaim 1, wherein each of the distal subannular anchoring element and theproximal subannular anchoring element is configured to be in contactwith subannular tissue after the cinching system is actuated to releasethe at least one of the distal subannular anchoring element or theproximal subannular anchoring element.
 6. The prosthetic heart valve ofclaim 5, wherein the valve frame includes a body that defines thecentral channel and an atrial collar coupled to a top edge of body, theatrial collar configured to be in contact with supra-annular tissue whenthe prosthetic heart valve is seated in the annulus of the native valve.7. The prosthetic heart valve of claim 1, wherein the cinching systemincludes at least one tether temporarily coupled to the proximalsubannular anchoring element.
 8. The prosthetic heart valve of claim 7,wherein actuating the cinching system to transition the at least one ofthe distal subannular anchoring element or the proximal subannularanchoring element from the first configuration to the secondconfiguration includes increasing a tension along the at least onetether to transition the proximal subannular anchoring element from anexpanded configuration to a folded configuration, and wherein actuatingthe cinching system to release the at least one of the distal subannularanchoring element or the proximal subannular anchoring element to thefirst configuration includes reducing the tension along the at least onetether to allow the proximal subannular anchoring element to transitionfrom the folded configuration to the expanded configuration.
 9. Theprosthetic heart valve of claim 1, wherein the valve frame defines thecentral channel when the prosthetic valve is in each of the compressedconfiguration and the expanded configuration.
 10. The prosthetic heartvalve of claim 1, wherein the valve frame includes a body that definesthe central channel, the body including a plurality of wire cells havingan orientation that allows compression of the prosthetic heart valvealong the central axis.
 11. A prosthetic heart valve, comprising: avalve frame defining a central channel extending along a central axis ofthe prosthetic heart valve, the valve frame including a distalsubannular anchoring element and a proximal subannular anchoringelement; a flow control component mounted within the central channel andconfigured to permit blood flow in a first direction along the centralaxis from an inflow end to an outflow end of the flow control componentand block blood flow in a second direction, opposite the firstdirection; and a cinching system releasably coupled to the valve framein at least one location and having a tether coupled to the proximalsubannular anchoring element, the prosthetic heart valve compressiblealong the central axis and a lateral axis perpendicular to the centralaxis to place the prosthetic heart valve in a compressed configurationto allow side-delivery of the prosthetic heart valve into a heart of apatient via a delivery catheter, each of the central axis and thelateral axis being perpendicular to a longitudinal axis of the deliverycatheter when the prosthetic heart valve is in the compressedconfiguration within the delivery catheter, the prosthetic heart valveconfigured to transition from the compressed configuration to anexpanded configuration when the prosthetic heart valve is released fromthe delivery catheter, the cinching system actuatable when theprosthetic heart valve is in the expanded configuration in the heart totransition the proximal subannular anchoring element from a firstconfiguration to a second configuration to allow the prosthetic heartvalve to be seated in an annulus of a native heart valve, the cinchingsystem actuatable after the prosthetic heart valve is seated in theannulus to release the proximal subannular anchoring element to thefirst configuration.
 12. The prosthetic heart valve of claim 11, whereinthe prosthetic heart valve in the expanded configuration has a firstheight along the central axis and a first lateral width along thelateral axis, and the prosthetic heart valve in the compressedconfiguration has a second height along the central axis less than thefirst height and a second lateral width along the lateral axis less thanthe first lateral width.
 13. The prosthetic heart valve of claim 12,wherein the prosthetic heart valve in the expanded configuration has afirst longitudinal length along a longitudinal axis perpendicular toeach of the central axis and the lateral axis, and the prosthetic heartvalve in the compressed configuration has a second longitudinal lengthalong the longitudinal axis greater than the first longitudinal length,the longitudinal axis of the prosthetic heart valve in the compressedconfiguration is parallel to the longitudinal axis of the deliverycatheter when the prosthetic heart valve is within the deliverycatheter.
 14. The prosthetic heart valve of claim 13, wherein theprosthetic heart valve in the expanded configuration has the firstlongitudinal length along the longitudinal axis when the proximalsubannular anchoring element is in the first configuration, and theprosthetic heart valve has a third longitudinal length along thelongitudinal axis less than the first longitudinal length when theproximal subannular anchoring element is in the second configuration.15. The prosthetic heart valve of claim 11, wherein the distalsubannular anchoring element is configured to be in contact withsubannular tissue when the prosthetic heart valve is seated in theannulus, and the proximal subannular anchoring element is in contactwith subannular tissue after the cinching system is actuated to releasethe proximal subannular anchoring element.
 16. The prosthetic heartvalve of claim 15, wherein the valve frame includes a body that definesthe central channel and an atrial collar coupled to a top edge of body,the atrial collar configured to be in contact with supra-annular tissuewhen the prosthetic heart valve is seated in the annulus of the nativevalve.
 17. The prosthetic heart valve of claim 16, wherein the cinchingsystem includes a steerable catheter temporarily coupled to the atrialcollar, the tether being at least temporarily coupled to the steerablecatheter.
 18. The prosthetic heart valve of claim 11, wherein actuatingthe cinching system to transition the proximal subannular anchoringelement from the first configuration to the second configurationincludes increasing a tension along the tether to transition theproximal subannular anchoring element from an expanded configuration toa folded configuration, and wherein actuating the cinching system torelease the proximal subannular anchoring element to the firstconfiguration includes reducing the tension along the tether to allowthe proximal subannular anchoring element to transition from the foldedconfiguration to the expanded configuration.
 19. The prosthetic heartvalve of claim 11, wherein the valve frame defines the central channelwhen the prosthetic valve is in each of the compressed configuration andthe expanded configuration.
 20. The prosthetic heart valve of claim 11,wherein the valve frame includes a body that defines the centralchannel, the body including a plurality of wire cells having anorientation that allows compression of the prosthetic heart valve alongthe central axis.
 21. A prosthetic heart valve, comprising: a valveframe defining a central channel extending along a central axis of theprosthetic heart valve, the valve frame including an atrial collarcoupled to a top edge of a body of the valve frame defining the centralchannel; a flow control component mounted within the central channel andconfigured to permit blood flow in a first direction along the centralaxis from an inflow end to an outflow end of the flow control componentand block blood flow in a second direction, opposite the firstdirection; and a cinching system releasably coupled to the valve framein at least one location, the prosthetic heart valve compressible alongthe central axis and a lateral axis perpendicular to the central axis toplace the prosthetic heart valve in a compressed configuration to allowside-delivery of the prosthetic heart valve into a heart of a patientvia a delivery catheter, each of the central axis and the lateral axisbeing perpendicular to a longitudinal axis of the delivery catheter whenthe prosthetic heart valve is in the compressed configuration within thedelivery catheter, the prosthetic heart valve configured to transitionfrom the compressed configuration to an expanded configuration when theprosthetic heart valve is released from the delivery catheter, thecinching system actuatable when the prosthetic heart valve is in theexpanded configuration in the heart to radially compress at least aportion of the body of the valve frame to reduce a circumference of atleast the portion of the body of the valve frame to allow the prostheticheart valve to be seated in an annulus of a native heart valve, thecinching system actuatable after the prosthetic heart valve is seated inthe annulus to allow at least the portion of the body of the valve frameto radially expand to allow the circumference of at least the portion ofthe body of the valve frame to increase.
 22. The prosthetic heart valveof claim 21, wherein the prosthetic heart valve in the expandedconfiguration has a first height along the central axis, a first lateralwidth along a lateral axis perpendicular to the central axis, and theprosthetic heart valve in the compressed configuration has a secondheight along the central axis less than the first height and a secondlateral width along the lateral axis less than the first lateral width.23. The prosthetic heart valve of claim 22, wherein the prosthetic heartvalve in the expanded configuration has a first longitudinal lengthalong a longitudinal axis perpendicular to each of the central axis andthe lateral axis, and the prosthetic heart valve in the compressedconfiguration has a second longitudinal length along the longitudinalaxis greater than the first longitudinal length, the longitudinal axisof the prosthetic heart valve in the compressed configuration isparallel to the longitudinal axis of the delivery catheter when theprosthetic heart valve is within the delivery catheter.
 24. Theprosthetic heart valve of claim 23, wherein the prosthetic heart valvein the expanded configuration has the first longitudinal length alongthe longitudinal axis when the portion of the body of the valve frame isradially expanded, and the prosthetic heart valve has a thirdlongitudinal length along the longitudinal axis less than the firstlongitudinal length when the cinching system is actuated to radiallycompress at least the portion of the body of the valve frame.
 25. Theprosthetic heart valve of claim 21, wherein the portion of the body ofthe valve frame includes at least a subannular portion of the body ofthe valve frame, the subannular portion of the body of the valve frameincluding a distal anchoring element and a proximal anchoring element.26. The prosthetic heart valve of claim 25, wherein each of the distalanchoring element and the proximal anchoring element is configured to bein contact with subannular tissue after the cinching system is actuatedto allow at least the subannular portion of the body of the valve frameto radially expand.
 27. The prosthetic heart valve of claim 21, whereinthe valve frame defines the central channel when the prosthetic valve isin each of the compressed configuration and the expanded configuration.28. The prosthetic heart valve of claim 21, wherein the body of thevalve frame includes a plurality of wire cells having an orientationthat allows compression of the prosthetic heart valve along the centralaxis.